Effects of Hypolipemic Treatment on Adipokines

Hyperlipidemia Clinical Trial

Official title:

The Effects of 90-day Monotherapies With Atorvastatin, Fenofibrate and Combined Therapy With Atorvastatin and Fenofibrate on Lipid Profile, Fasting Plasma Glucose, Proinflammatory Cytokines and Adipokines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099176
• Other study ID #: Ministry of Science
• Status: Completed
• Phase: N/A
• First received: April 5, 2010
• Last updated: April 8, 2010
• Start date: May 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2006
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

The study is planned to show whether monotherapies or combined hypolipemic therapy influence the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 64 Years

Eligibility

Inclusion Criteria:

• Age (35-64yr)

• Primary hyperlipidemia (Total cholesterol >200mg/dl, Triglycerides >150mg/dl)

• Impaired fasting glycemia (glycemia 100-125mg/dl)

• For women:

• Menopause (>12 months)

• Post hysterectomy

• Mechanical contraception

• Obtained informed consent

Exclusion Criteria:

• Secondary hyperlipidemia

• Morbid obesity (BMI>40kg/m2)

• Alcohol or drug abuse

• Acute or chronic inflammation

• Congestive Heart Failure (NYHA III or IV)

• Unstable Ischaemic Heart Disease

• Moderate or severe hypertension

• Cancer in less than 5 years

• Chronic kidney disease (stage III-V)

• Liver failure

• Diabetes

• Oral contraception

• Not compliant patient

• Laboratory results:

• alanine transferase (>3xULN)

• creatine kinase (>5xULN)

• haemoglobin (<10/dl)

• PLT (<100G/l)

• WBC (<3,5G/l or >10G/l)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Impaired Fasting Glycemia

Intervention

Drug:
• To compare monotherapies and combined therapy with each other
Each patient received two tablets per day. Time interval between pills - 12 hours. In monotherapies patients received one active tablet and one placebo, in combined treatment both pills were active and in placebo group patients taken two placebo tablets

Locations

Country	Name	City	State
Poland	Department of Pharmacology	Katowice	Slaskie

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Silesia	Ministry of Scientific Research and Information Technology, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adipokines	Serum concentration of leptin, adiponectin and resistin on Day 90 of the treatment.	Day 90	No
Secondary	Proinflammatory cytokines	Interleukin-6 and TNF alpha serum concentration on the Day 30 of the treatment	Day 30	No
Secondary	Adipokines	Serum concentration of leptin, adiponectin and resistin on Day 30 of the treatment.	Day 30	No
Secondary	Proinflammatory cytokines	Interleukin-6 and TNF alpha serum concentration on the Day 90 of the treatment	Day 90	No